HFN-Quality Analyst

With a mantra of Empowering Human Potential, Hanger, Inc. is the world's premier provider of orthotic and prosthetic (O&P) services and products, offering the most advanced O&P solutions, clinically differentiated programs and unsurpassed customer service. Hanger's Patient Care segment is the largest owner and operator of O&P patient care clinics nationwide. Through its Products & Services segment, Hanger distributes branded and private label O&P devices, products and components, and provides rehabilitative solutions to the broader market. With 160 years of clinical excellence and innovation, Hanger's vision is to lead the orthotic and prosthetic markets by providing superior patient care, outcomes, services and value. Collectively, Hanger employees touch thousands of lives each day, helping people achieve new levels of mobility and freedom.

Position Overview:

To serve as a quality analyst/technician and assist with maintaining Quality Management System and improvement initiatives across O&P fabrication sites.

Principal Duties and Responsibilities (Essential Functions):

• Responsible for maintaining and improving the Quality Management System to meet pertinent quality standards.
• Design and/or assist with QC inspection of devices.
• Assist site and network efforts to improve products, processes related to quality, compliance and/or productivity.
• Ability to create and process CAPAs and Nonconformance investigations in a team environment.
• Assist with customer complaint management.
• Assist/create programs, processes, and work instructions in a team environment.
• Conduct Quality-related training.
• Assist/lead internal audits processes within internal functional areas and/or vendors as required.

• Maintains and further enhances a positive, engaged, accountable organizational climate.
• Actively engage with other internal functional areas to address quality improvement initiatives

Job Complexity:

Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.

Supervision Received and Exercised:

 Normally receives detailed instructions on all work.

In Office: M-F 8-5 some flexiblity either way

Preferred

• 2-3 years of related experience
• Experience in manufacturing environment

• Experience in manufacturing of medical devices
• Background in orthotics and prosthetics is a plus
• Experience in internal and external audits
• Experience in nonconformance investigations

High school diploma or GED

Associates or bachelor's degree in STEM or related field is preferred.

• Strong knowledge and understanding of 21 CFR Part 820 requirements and other applicable regulations, such as ISO 13485.
• Familiarity with quality tools and methodologies, such as root cause analysis, statistical process control, and risk management.
• Excellent attention to detail and strong analytical skills to assess and interpret data, identify trends, and make data-driven decisions.
• Effective communication skills, both verbal and written, with the ability to articulate complex quality concepts to diverse audiences.
• Proficient in using quality management software, document control systems, and Microsoft Office applications.
• Strong organizational and time management skills to manage multiple tasks and priorities concurrently.
• Ability to work collaboratively in a team environment and interface with cross-functional stakeholders.
• Quality certifications, such as Certified Quality Technician (CQT) or Certified Quality Auditor (CQA) are a plus.

• Competitive Compensation Packages
• 8 Paid National Holidays & 4 additional Floating Holidays
• PTO that includes Vacation and Sick time
• Medical, Dental, and Vision Benefits
• 401k Savings and Retirement Plan
• Paid Parental Bonding Leave for New Parents
• Flexible Work Schedules and Part-time Opportunities
• Generous Employee Referral Bonus Program
• Mentorship Programs- Mentor and Mentee
• Student Loan Repayment Assistance by Location
• Relocation Assistance
• Regional & National traveling CPO/CO/CP opportunities
• Volunteering for Local and National events such as Hanger’s BAKA Bootcamp and EmpowerFest

Hanger, Inc. is committed to providing equal employment opportunity in all aspects of the employer-employee relationship. All conditions and privileges of employment are administered to all employees without discrimination or harassment because of race, religious creed, color, age, sex, sexual orientation, gender identity, national origin, religion, marital status, medical condition, physical or mental disability, military service, pregnancy, childbirth and related medical conditions, special disabled veteran status, or any other classification protected by federal, state, and local laws and ordinances. The company will comply with all applicable state or local fair employment laws that forbid discrimination or harassment on the basis of other protected characteristics. Retaliation against any employee for filing or supporting a complaint of discrimination or harassment is prohibited.

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